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Bayer has acquired the OTC drug business of Roche for approximately $2.96 billion, a transaction that makes the company one of the top three OTC businesses worldwide.
Sen. Hillary Clinton (D-N.Y.) has joined the chorus of federal lawmakers seeking more detail about the rationale behind the FDA’s decision last month to deny OTC status for Barr Pharmaceutical’s Plan B emergency oral contraceptive.
A bill overwhelmingly passed by the House to prohibit OTC sales of dozens of steroid precursors would require HHS to evaluate the risks of other dietary supplements that contain substances similar to those listed in the legislation.
The global pharmaceutical market will push past $900 billion in 2008, due to an aging population and increasing healthcare awareness worldwide, according to a new report by a market analysis firm.
The nation's second-largest manufacturer of private-label OTC products was recently issued an FDA warning letter documenting more than a dozen deviations from current good manufacturing practice (cGMP) regulations.
Manufacturers of OTC antidiarrheal drugs containing bismuth subsalicylate can include an indication for relief of traveler’s diarrhea in product labeling, according to the FDA.
The FDA was not bowing to political pressure in its recent decision to reject Barr Pharmaceutical’s bid for OTC status for its Plan B emergency oral contraceptive, but rather the agency’s decision was based on the best scientific analysis of the available data, according to a top FDA official.
Manufacturers of OTC antidiarrheal drugs containing bismuth subsalicylate can include an indication for relief of traveler’s diarrhea in product labeling, according to the FDA.
All Rx drugs and certain OTC products would be required to include an FDA toll-free telephone number for consumers to report side effects, as well as a statement that the contact number is not intended for seeking medical advice, according to a proposed rule the agency issued last week.
Drugmakers will have to affix linear bar codes to the exterior labeling and interior unit-dose packaging of most prescription and certain OTC drug products commonly used in hospitals and other healthcare settings, under a new FDA final rule released last week.